Randomized Controlled Trial Prospective Single-center Open Evaluating the Efficacy of Supplementation (Adapted to the Post-operative Period) Current Protein After Bariatric Surgery Like Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Changes in lean mass (kg) will be assessed at the level of whole-body dual-energy X-ray absorptiometry (DXA)
研究概览
简要总结
The main objective will be to evaluate the effect at 5 weeks of nutritional management associated with protein supplementation (adapted to the post-operative period) on the maintenance of lean body mass at the whole body in obese patients after a sleeve gastrectomy.
Secondary objectives will assess protein intake, food safety, the effect of protein supplementation on body fat in the entire body and the metabolic rate and the impact on quality of life and post-operative joint pain.
详细描述
The main objective will be to evaluate the effect at 5 weeks of nutritional management associated with protein supplementation (adapted to the post-operative period) on the maintenance of lean body mass at the whole body in obese patients after a sleeve gastrectomy.
Secondary objectives will assess protein intake, food safety, the effect of protein supplementation on body fat in the entire body and the metabolic rate and the impact on quality of life and post-operative joint pain.
There is still no study evaluating the protein supplementation adapted patients after sleeve gastrectomy on maintaining lean body mass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •surgical management of sleeve gastrectomy kind
排除标准
- •food allergies
- •Weight> 135 kg (maximum weight supported by the DXA)
- •orthopedic prosthesis (hip, knee ...) that would make it impossible to interpret the measurement of DXA
- •History of bariatric surgery: adjustable gastric banding, vertical banded gastrectomy ...
研究组 & 干预措施
usual dietary management
Control group: usual dietary management Following the intervention, the stomach of patients underwent many changes
care of with usual dietary protein supplementation
Intervention group: Usual dietary management with protein supplementation (30g) in addition to the usual inputs
干预措施: protein supplementation (Other)
结局指标
主要结局
Changes in lean mass (kg) will be assessed at the level of whole-body dual-energy X-ray absorptiometry (DXA)
时间窗: up to 1 month
次要结局
- the quality of life(up to 5 years)
- food diary(5 weeks after the hospital discharge)
- change rate IGF1, IGFBP3(up to 5 years)